Cleared Traditional

K252433 - Sonio Detect (v3)

K252433 is the FDA 510(k) clearance for Sonio Detect (v3) by Sonio. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K252433 · Sonio · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
227d
Days
Class 2
Risk

K252433 is an FDA 510(k) clearance for the Sonio Detect (v3). Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Sonio (Paris, FR). The FDA issued a Cleared decision on March 16, 2026 after a review of 227 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sonio devices

Submission Details

510(k) Number K252433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2025
Decision Date March 16, 2026
Days to Decision 227 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 107d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 779
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